Judge Robert W. Sweet of the U.S. District Court has invalidated patents related to the BRCA1 and BRCA2 genes that are held by Myriad Genetics. In addressing the issue of whether isolated human genes and the comparison of their sequences are patentable, The 88-year-old Judge Sweet has ruled that the patents lacked novelty since genes are part of nature.
The Plaintiffs included the American Civil Liberties Union on behalf of women’s health groups, geneticists and scientific associations representing approximately 150,000 researchers, pathologists, laboratory professionals and individuals diagnosed with breast cancer, challenged patents held by Myriad Genetics and the University of Utah Research Foundation on grounds that genes are “products of nature and cannot be patented.” They were represented by the ACLU and by the Public Patent Foundation of the Cardozo School of Law, Yeshiva University. The plaintiffs managed to invalidate seven patents related to the human BRCA1 and BRCA2 genes, which indicate susceptibility to Breast Cancer.
The United States Patent Office has a long-established practice of granting patents on DNA sequences in the form of “isolated DNA,” with some 17,000 gene patents issued and over 30,000 applied for. Unlike business method patents and methods of therapeutic treatment which are both patentable in the US only, other countries also see genes as legitimate patentable material.
The District Court ruled in favor of the Plaintiffs, granting summary judgment and reasoning that the patent claims covered “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
Judge Sweet reasoned that DNA is a physical embodiment of biological information, and is distinct from any other chemical found in nature. Isolating DNA neither alters its fundamental quality, nor does it alter the information that DNA encodes. Since the patents are directed to sequences found in nature, they are unpatentable subject matter.
This ruling is not binding on other federal courts, and does not apply to other types of patents. However, we exect the case to be appealed to the Court of Appeals for the Federal Circuit, and it may ultimately go to the Supreme Court.
The argument centers round whether isolating a gene sequence is discovery or classification, or is it inventing. Philosophically, I would tend to go with the honorable judge and consider there to be a lack of novelty, or, at least a lack of inventive step in patents for gene sequences. Nevertheless, as with pharmaceutical patents, being able to monetize gene research requires being able to obtain ownership over them, which requires them to be considered patentable inventions. Without patent protection being available, there may not be the resources available for doing genetic research.
The first Patent Act of the U.S. Congress, entitled “An Act to promote the progress of useful Arts”, was passed on April 10, 1790. It legislated for the grant of a patent to an inventor fulfilling the appropriate formalities “if they shall deem the invention or discovery sufficiently useful and important”. Thus from the very earliest days in the US, patents discoveries were considered patentable if useful.
In re Bergy, the Court of Customs and Patent Appeals (the predecessor of the modern Federal Circuit) upheld a patent directed toward a purified version of an antibiotic producing strain of streptomycin, a substance that appears in nature in an unpurified state. In Chakrabarty, the Supreme Court held that genetically modified micro-organisms not found in nature can be patented. The Supreme Court also held in J.E.M that newly-developed plant breeds are patentable. The Supreme Court has not, however, specifically considered the patentability of human genes.
Nevertheless, the patents covering the BRCA1 and BRCA2 genes are not unusual or unique. The United States Patent Office has been granting patents for chemical compositions based upon human extractions for over 100 years. The first patent for such a chemical was granted in 1907 for adrenaline. Insulin was patented in 1923.
Neither chemical and certainly no gene string occurs naturally in isolation. Those favoring patentability argue that the extraction and characterization is essentially inventing. In terms of genetics, inventors must:
(1) identify novel genetic sequences
(2) specify the sequence’s product
(3) specify how the product functions in nature –ie, its use
(4) enable one skilled in the field to use the sequence for its stated purpose
By linking the utility requirement to use, the argument that the invention is not novel and is naturally occurring substance is emphasized.
In the US, the Patent Office currently interprets Chakrabarty as allowing the patenting of living things, regardless of whether they are genetically modified (Chakrabarty) or isolated and purified by man (Bergy). Further, the Patent Office takes the position that genes are treated as chemical compounds and qualify for potential patenting as compositions of matter.
It should be noted that the claims challenged in the Breast Cancer Susceptibility Gene patents include two types: (1) composition claims, and (2) method/process claims. The first set of claims was invalid as a “product of nature,” and the second set of claims was invalid as representing an abstract idea. There were also claims to a kit for diagnosis and to a probe. Such claims were not challenged.
The case: Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., No. 09-Civ-4515 (S.D.N.Y.)
Researchers at Duke University analyzed U.S. Patent No. 5,747,282 and compared a 15-mer oligonucleotide in the BRCA1 gene described by one of the patent’s claims against gene sequences in GenBank, the NIH genetic sequence database. They found that 80% of cDNA and mRNA in the database contain at least one oligonucleotide covered by the claim.
The researchers conclude that any ‘isolated’ DNA molecules that include such 15bp nucleotide sequences would fall under the claim as granted by the U.S. Patent and Trademark Office (USPTO). Thus, some 300,000 oligonucleotides in chromosome 1, which does not contain the BRCA1 gene, are, nevertheless, covered by the claim, and anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim.
As with the infamous Pfizer patent for Viagra which covers very many molecules not known to be active, it seems that gene patents, like pharmaceutical patents, tend to be too broad. Such patents are filed for early on during research, prior to a deep understanding of what aspects are commercially valuable.
Time will tell how this controversial ruling by a man in his late eighties will stand up to Appeal. In the meantime, there is a lot of research money and patent activity that will go on hold.
Gene Patents in Israel
Back in October 2008, in Circular M.N. 64, the Israel Commissioner of Patents announced that gene sequences can now be patented in Israel. See Gene Sequences are now patentable in Israel. However, that ruling ignored the fundamental issue of whether such things are fairly described as being inventions and is also probably ultra-vires. So if challenged in Court, a judge could over-rule the Commissioner.
Gene Patents elsewhere
The same issue is being considered in Australia, see Gene Patents Under Attack and the European Court of Justice has also been asked to clarify through interpretation of Directive 98/44 whether a DNA sequence is entitled to patent protection as a compound as such, or only under circumstances where the DNA performs its function.
For an interesting rave by Gene Quinn, see Hakuna Matada, the ACLU Gene Patent Victory Will Be Short Lived.
Posted by Dr Michael Factor 
